MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM; FEMUR INTRAMEDULLARY NAIL

Model Number	P12.5-80B305
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that a revision procedure occurred due to the nail being damaged surrounding the male-female junction site.The revision procedure was completed with no adverse consequences to the patient.
Event or Problem Description
It was reported that a revision procedure occurred due to the nail being damaged surrounding the male-female junction site.The revision procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The investigation revealed that a precice antegrade femur piriformis straight nail, 12.5mm x 305mm, appeared to have damage around the male-female junction site.The damage was believed to have occurred 2-weeks post-op, but the reporter cannot confirm this.It was reported that a revision procedure was completed with no adverse consequences to the patient.The nail was received by globus medical for investigation.A visual inspection was performed that confirmed that the nail had an approximate 7.5mm crack in the housing tube at the male-female junction.Additionally, one-half of the anti-rotation lug was missing while the other half remained in the housing tube.Functional testing was not performed as the missing anti-rotation lug would not allow the nail to properly function.The iqc inspection report for the lot of housing tube and anti-rotation lug used for the nail was reviewed, and the housing tube met all required specifications per the engineering drawing.Based on provided information, no event in particular had occurred which could have led to the nail breaking.However, based on the type of breakage observed, it is possible that the nail broke due to stress generated from weight bearing activities.A bending moment is created when weight bearing loads are placed on the distraction rod, causing stress along the housing tube portion where the crown is seated.The wall of the housing tube is thinnest at this location, causing a crack in the tube when enough stress is applied to that location.A review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all the required inspections before shipment.The associated risk document was reviewed, and the failure mode, effects, and harms potentially related to the reported event have been identified and mitigated.Furthermore, the complaint rate is within the estimated rate in the risk documentation associated with this product.Based on this risk assessment, no new or additional risk evaluation is necessary.

• Brand Name: PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: FEMUR INTRAMEDULLARY NAIL
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 21894440
• Report Number: 3006179046-2025-00110
• Device Sequence Number: 19715505
• Product Code: HSB
• UDI-Device Identifier: 00812258020347
• UDI-Public: 00812258020347
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P12.5-80B305
• Device Lot Number: 4042501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown